UNIVERSITY OF KENTUCKY



                           LEXINGTON. KENTUCKY 40506

OFFICE OF THE PRESIOENT                                 April 12, 1974




    MEMORANDUM


    To:      University Faculty and Administration

    From:    Otis A. Singletary

    Subject: Protection of Human Subjects Involved in Research, Development,
              and Demonstration Activities


    Studies using human subjects have become a matter of deep concern to the
    public at large and to the universities under whose aegis most such investi-
    gations are undertaken. These concerns embrace the physical, psychological,
    social and legal protection of the subjects, and involve the moral and ethical
    questions attendant thereto. Public interest in this matter has resulted in the
    formulation of requirements which must be met when human investigations are
    undertaken in the biomedical field, and are clearly stated in research con-
    tracts and grants from a number of organizations such as the Department of
    Health, Education, and Welfare and the Food and Drug Administration. These
    regulations require intra-institutional review and a contractual assurance of
    such review by the university to the granting agency.

    The University of Kentucky has adopted the posture that each research, devel-
    opment, or demonstration activity involving human subjects that originates in
    an academic program of this institution is subject to review, whether or not
    the study is supported by a granting agency or an agency that requires a re-
    view. Therefore, I have created the Human Investigations and Studies Com-
    mittee, a University committee appointed by and responsible to me, which
    has the charge of insuring that appropriate reviews are conducted. Staff sup-
    port for the Committee is provided by the Administrative Assistant for the
    Human Investigations and Studies Committee, a position located in the Office
    of Sponsored Projects Administration.

    The Committee functions through two subcommittees, one which deals with
    human investigations originating from the five colleges of the Medical Cen-
    ter, and one which reviews studies from units outside the Medical Center
    which are directly involved in the academic programs of instruction, re-
    search and service. Procedures for reviewing and monitoring of protocols



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